The Federal Court dismissed a judicial review by Bayer Inc. and Regeneron Pharmaceuticals, Inc. of the Minister of Health’s decision allowing Biosimilar Collaborations Ireland Limited (BCIL) to adopt the Notice of Allegation served by BGP Pharma ULC (d.b.a. Viartis Canada) relating to an aflibercept biosimilar. BCIL assumed the title of “second person” under the Patented Medicines (Notice of Compliance) Regulations, with all the associated benefits and burdens, when it purchased Viartis’ new drug submission. BCIL did not have to serve its own NOA to comply with section 5 of the Regulations (the provision that requires the sending of a notice of allegation by the second person).
In May 2022, after filing an NDS for YESAFILI, Viartis served an NOA addressing two patents listed on the Patent Register against EYLEA. The patents are owned by Regeneron, and EYLEA is marketed by Bayer in Canada. Bayer and Regeneron then commenced an action against Viartis under subsection 6(1) of the Regulations (Court File No. T-1241-22). Ownership of the NDS for YESAFILI was subsequently transferred to BCIL in early 2023.
Following submissions from Bayer, Regeneron, Viartis, and BCIL, the Minister decided that BCIL could adopt the steps previously taken by Viatris to comply with section 5 of the Regulations, including service of the Viartis NOA, and that BCIL should be added as a defendant in T-1241-22 for the purpose of the Minister’s administration of section 7. The Minister also advised of its view that the stay under subsection 7(1)(d) of the Regulations continued to apply, and BCIL was bound by the outcome of T‑1241-22.
Justice Furlanetto applied the reasonableness standard to the Minister’s decision because the Minister’s analysis was restricted to section 5 of the Regulations. In the Court’s view, a correctness review did not apply because the Court does not have concurrent jurisdiction with the Minister to interpret section 5 at the first instance.
The Court upheld the decision as reasonable, finding that the scheme of the Regulations and the mechanism of handling submissions under the FDR supports a view that the NOA and its service would be transferred to BCIL. More specifically, the Court relied on the fact that an ownership change is administrative and does not change the substance of the submission. Following the transfer of ownership, the successor second person “assumes both the benefits and regulatory responsibilities related to the drug submission,” including any Form Vs prepared by the predecessor, and by extension any NOAs.
The Court rejected Bayer’s assertion that the Viartis NOA became a legal nullity as a result of the transfer. Paragraph 5(3)(d) of the Regulations provides, inter alia, that the second person must provide the first person, without delay, any portion of their submission produced with the NOA that has changed “on or before […] the day of the disposition of any action that has been brought under subsection 6(1).” The Court therefore held, “the second person is not required to serve a new NOA […] every time there is a change to the second person’s submission. The second person is simply required to provide notice of the changes made.”
The Court also rejected that BCIL was required to withdraw the Viartis NOA, as a change in manufacturer is not one of the circumstances requiring withdrawal under subsection 5(6) of the Regulations.
By contrast, the Court found that “an interpretation of the Regulations that requires a successor second person to reserve the same NOA on a first person would be contrary to the objectives of the Regulations and the balance set out in Biolyse.”
The Court further held that the 24-month stay imposed by paragraph 7(1)(d) of the Regulations applies once an action under subsection 6(1) has commenced, which prevents the Minister from issuing a Notice of Compliance in relation to that NDS and in respect of the successor second person, even if they have not yet been named as a defendant to the action. There was no risk that an NOC would issue to BCIL before it became a defendant in T-1241-22.
Finally, the Court disagreed that BCIL’s adoption of the Viartis NOA frustrated Bayer’s ability to renounce the 24-month stay. In part because Bayer did not renounce the stay when it commenced a separate action against BCIL (Court File No. T-581-23), the Court rejected that the identity of the second person had any bearing on Bayer’s paragraph 7(5)(b) choice.
A copy of the decision is available here.